Airway Management, Intubation Intratracheal
Conditions
Keywords
Intubation, anesthesia residents, videolaryngoscope, direct laryngoscope
Brief summary
The usual intubation technique in the operating room is based on direct laryngoscopy, using a standard Macintosh laryngoscope. However, this skill is not easy to acquire and requires adecuate training. Videolaryngoscopes are becoming a widely accepted airway management technique. because offer better view of the glottis and are easy to use. In addition, indirect laryngoscopes are useful for tracheal intubation by novice operators because of the feedback that supervisors can offer during intubation. The goal of this clinical trial is to learn which intubation technique performed by residents of anesthesia in the operating room is better. The main questions it aims to answer are: * Which intubation technique is more effective for achieving first-attempt intubation? * Which intubation technique results in fewer complications? Researchers will compare both intubation techniques performed by anesthesia residents in the operating room in adult anesthesia cases.
Detailed description
The study will randomize, by means of a computer-generated randomization, approximately 1008 adults in two groups: Conventional group (Laryngoscope with Macintosh Blade) and Videolaryngoscope group (Mac-Style Blade) to be intubated in the operating room by an anesthesia resident. Success rate of the selected technique (first attempt), overall success rate, number of attempts, complications, and duration of insertion for technique will be noted.
Interventions
DEVICEIntubation with standard laryngoscope
Anesthesia resident will intubate using a standard laryngoscope.
DEVICEIntubation with video laryngoscope
Anesthesia resident will intubate using a videolaryngoscope (Storz C-MAC, McGrath, Glidescope or other videolaryngoscope)
Sponsors
Hospital Universitario Lucus Augusti
Hospital Clinico Universitario de Santiago
Complexo Hospitalario de Ourense
Complejo Hospitalario Universitario de Pontevedra
Complexo Hospitalario Universitario de A Coruña
Complejo Hospitalario Universitario de Vigo
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital Arquitecto Marcide. Ferrol. A Coruña. (Spain)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Intervention model description
Laryngoscope Group: anesthesia resident intubation with Macintosh standard laryngoscope . Videolaryngoscope Group: anesthesia resident intubation with videolaryngoscope Mac-Style Blade.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥18 years old * Patients who need to be tracheal intubated for a surgical intervention in the surgical area. * Intubation performed by an anesthesia resident.
Exclusion criteria
* Need for tracheal intubation with a device other than videolaryngoscopy or direct laryngoscopy (fiberoptic bronchoscope, tracheostomy...). * Context of a Difficult Airway Management. * Refusal of the patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in the first attempt success rate (percentage) | During intubation | Success on the first attempt is defined as successfully passing the tube through the vocal cords in a single laryngoscopy attempt and inserting the endotracheal tube into the trachea |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing the glottic view in the modified Cormack-Lehane scale between the two approaches | During intubation | Modified Cormack-Lehane grade of glottic view: * I: full view of the glottis * IIa: partial view of the glottis * IIb: arytenoid or the posterior part of the vocal cords just visible * III: only epiglottis visible * IV: neither glottis nor epiglottis visible Cormack-Lehane grade of glottic view |
| Difference in percentage of "easy intubation" | During intubation | To compare the difference in "easy intubation," defined as a Cormack-Lehane grade I-IIa glottic view and successful intubation on the first attempt, between the two intubation approaches. |
| Duration of laryngoscopy and tracheal intubation | During intubation | The interval (in seconds) between the first insertion of a laryngoscope blade into the mouth and the final placement of a tube in the trachea. |
| Number of attempts to cannulate the trachea with an endotracheal tube | During intubation | Number of attempts to cannulate the trachea with an endotracheal tube |
| Number of attempts to cannulate the trachea with a bougie. | During intubation | Number of attempts to cannulate the trachea with a bougie |
| Need to change the device for intubation | During intubation | Need to replace by another videolaryngoscope, a different angled blade, requirement for a fiberoptic bronchoscope... |
| Need for additional airway equipment | During intubation | Airway equipment: bougie, stylet, other videolaryngoscope, others. |
| Operator-assessed difficulty of intubation | During intubation | Operator-assessed difficulty of intubation * without difficulty * mild difficulty * moderate difficulty * severe difficulty |
| Use of external laryngeal pressure | During intubation | External laryngeal pressure: Sellick maneuver or BURP |
| Reason for failure to intubate on the first attempt | During intubation | Reason for failure among those who did not meet the primary outcome (successful intubation on the first attempt): * Inadequate view of the larynx * Inability to intubate the trachea with an endotracheal tube * Inability to cannulate the trachea with a bougie * Attempt aborted due to change in patient condition (e.g., worsening hypoxemia, hypotension, bradycardia, vomiting, bleeding) * Technical failure of the laryngoscope (e.g., battery, light source, camera, screen) * Other |
| Complications during intubation | Participants will be followed from the beginning of the intervention to 10 minutes after the intervention | Complications during the procedure and within the following 10 minutes, including: hypotension (SBP \< 80 mmHg), hypotension (SBP \< 65 mmHg), O₂ saturation \< 90%, O₂ saturation \< 80%, bronchoaspiration, esophageal intubation, dental injury, airway injury, and others. |
Countries
Spain
Contacts
PRINCIPAL_INVESTIGATORMaría Bermúdez María Bermúdez López, MD
Hospital Universitario Lucus Augusti
Outcome results
None listed